ModerateClass IITerminated

FDA Devices recall · Reported February 7, 2018

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HE

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0496-2018.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Pre-procedural issues related to software defects

Recall #: Z-0496-2018
Affected scope: 198 devices
Initiated: October 2, 2017

Compiled from official public sources by the publisher. · Updated September 2026

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Edwards Lifesciences, LLC recalled Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (S… - a moderate-severity action.

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (S… was recalled by Edwards Lifesciences, LLC in February 7, 2018. Reason: Pre-procedural issues related to software defects. Check the official notice for the remedy. Verify recall #Z-0496-2018 with the FDA Devices before acting.

The recall

Edwards Lifesciences, LLC issued this moderate-severity FDA Devices recall-Pre-procedural issues related to software defects.

Moderate
severity level: 198 units
affected scope: Class II
classification: February 7, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0496-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

Reason for recall

Pre-procedural issues related to software defects

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0496-2018
Date reported	February 7, 2018
Date initiated	October 2, 2017
Recalling firm	Edwards Lifesciences, LLC
Firm location	Irvine, CA
Affected scope	198 devices
Distribution	US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

198 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0496-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Pre-procedural issues related to software defects

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0496-2018.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

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This recall: FDA Devices, reported February 7, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026